FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cardiovascular ×
18,151 results
14233–14256 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 22, 1986
NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20
K863494 · DRT
Advantage Medical Systems, Inc.
Cardiovascular · 104d
Cleared Dec 22, 1986
RNET SYSTEM, IV RECEIVING TERMINAL, TRANSMITTER
K863716
Futurecare Systems, Inc.
Cardiovascular · 90d
Cleared Dec 22, 1986
KENZ-ECG 102
K863965 · DXK
Compumed, Inc.
Cardiovascular · 73d
Cleared Dec 11, 1986
MODIFIED SARNS MEMBRANE OXYGENATOR
K863902 · DTX
3M Health Care, Sarns
Cardiovascular · 65d
Cleared Dec 11, 1986
STOCKERT-SHILEY CAPS BATTERY MODULE
K863960 · DTQ
Shiley, Inc.
Cardiovascular · 62d
Cleared Dec 11, 1986
MODIFIED VSM 2 VITAL SIGNS MONITOR
K864665 · DXN
Physio-Control Corp.
Cardiovascular · 10d
Cleared Dec 11, 1986
MODIFIED LIFESTAT 200
K864666 · DXN
Physio-Control Corp.
Cardiovascular · 10d
Cleared Dec 10, 1986
MODEL 456 ELECTROCARDIORECORDER RECORDER
K863652 · DPS
Del Mar Avionics
Cardiovascular · 83d
Cleared Dec 10, 1986
TRIOS-M VS-1 PULSE GENERATOR
K863878 · DXY
Biotronik Sales, Inc.
Cardiovascular · 65d
Cleared Dec 10, 1986
NEOS-M VS-1 PULSE GENERATOR
K863879 · DXY
Biotronik Sales, Inc.
Cardiovascular · 65d
Cleared Dec 10, 1986
SEA MED MODEL 6000
K863903 · DTE
Seamed Corp.
Cardiovascular · 64d
Cleared Dec 10, 1986
Q-SCAN II AND Q-SCAN III
K864149 · DSI
Quinton, Inc.
Cardiovascular · 49d
Cleared Dec 08, 1986
CRITICALC
K860854 · DQK
Cygnus of South Florida, Inc.
Cardiovascular · 276d
Cleared Dec 08, 1986
EM II DISPOSABLE ELECTRODE
K863540 · DRX
Electromed Intl., Ltd.
Cardiovascular · 88d
Cleared Dec 08, 1986
EM II STRESS TEST ELECTRODE
K863584 · DRX
Electromed Intl., Ltd.
Cardiovascular · 84d
Cleared Dec 05, 1986
DSP100 AMPLIFIER
K860814 · DQC
Intl. Acoustics, Inc.
Cardiovascular · 276d
Cleared Dec 05, 1986
LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC
K862463 · DRT
Nihon Kohden America, Inc.
Cardiovascular · 158d
Cleared Dec 05, 1986
AVTECH LWP*(LOW POROSITY) MWP*(MEDIUM POROSITY)
K862697 · DSY
Advanced Vascular Technologies, Inc.
Cardiovascular · 143d
Cleared Dec 05, 1986
ULTRA SOFTWARE MODULE: MODEL 2016
K863046 · KRG
Cardiac Pacemakers, Inc.
Cardiovascular · 115d
Cleared Dec 05, 1986
EPICARDIA, PC/FD
K863643 · DSI
Medicomp, Inc.
Cardiovascular · 78d
Cleared Dec 05, 1986
TELECTRONICS SREW-IN/SLIM LINE PACING LEADS
K864098 · DTB
Daig Corp.
Cardiovascular · 45d
Cleared Dec 05, 1986
MODEL 366-23 ADAPTAID(TM) STEP-DOWN ADAPTER
K864428 · DTB
Intermedics, Inc.
Cardiovascular · 23d
Cleared Dec 05, 1986
MODEL 486-05 POLYFLEX(R) IMPLANTABLE PACING LEAD
K864564 · DTB
Intermedics, Inc.
Cardiovascular · 16d
Cleared Dec 05, 1986
ACS HI-TORQUE FLOPPY GUIDE WIRE, 0.018 INCH
K864585 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 18d